ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity
ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device (AED) that could fail to function in an emergency situation. However, no illnesses or injuries have been reported, and the hazard is theoretical rather than based on actual harm, so the score is limited to 3 per the rubric.
Plain-English summary
ZOLL Medical Corporation is recalling 73 Powerheart G5 automated external defibrillator (AED) units. These devices may fail their internal self-test when exposed to prolonged extreme environmental conditions, specifically extreme temperatures and/or humidity. When an AED fails its self-test, it may not operate properly if needed in a cardiac emergency.
The recall affects four models: G5S-01C, G5S-02C, G5S-10C, and G5S-11C. The affected units have been distributed nationwide throughout the United States and internationally to 47 countries and territories.
Organizations and individuals with affected AEDs should contact ZOLL Medical Corporation immediately for instructions regarding device inspection, testing, or replacement. Facility staff should verify that their devices' serial numbers match the recall notification and follow manufacturer guidance without delay.
The recalled product
- Product
- Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Defibrillator
- Hazard
- self-test-failure
- environmental-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: (1) G5S-01C
- (2) G5S-02C
- (3) G5S-10C
- (4) G5S-11C
- UDI-DI: (1) 00812394021246
- (2) no UDI
- (3) no UDI
- (4) no UDI
- Serial Numbers: (1) D00000089561
- D00000089566
- D00000089577
- D00000105587
- D00000111542
- D00000111556
- D00000111640
- D00000111706
- D00000111718
- D00000113136
- D00000113147
- D00000113175
Distribution
Distributed nationwide across the United States.
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